Fasteners and fastener delivery devices for affixing sheet-like materials to bone or tissue

ABSTRACT

A fastener for attaching a sheet-like implant to tissue or bone. The fastener includes a first arm having a proximal end and a distal end, a second arm having a proximal end and a distal end, and a bridge extending therebetween. Each of the first and second arms include a trunk portion defining at least a portion thereof, the trunk portion having a cavity therein and an aperture through a wall thereof. A claw is disposed in the cavity which is moveable from a first delivery position to a second deployed position. A pull member engages each claw to move the claw from the delivery position to the deployed position.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/721,617 filed on May 26, 2015, which is a continuation of U.S.application Ser. No. 13/717,515, filed on Dec. 17, 2012, which claimsthe benefit of U.S. Provisional Patent Application Ser. No. 61/577,632filed on Dec. 19, 2011, the disclosures of each incorporated herein byreference.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD OF THE INVENTION

The present invention relates generally to orthopedic medicine andsurgery. More particularly, the present invention relates to methods andapparatus for delivery and fixation of sheet-like materials, such as fortreating tendons or like tissue of articulating joints, such as tendonsin the rotator cuff of the shoulder.

BACKGROUND OF THE INVENTION

The glenohumeral joint of the shoulder is found where the head of thehumerus mates with a shallow depression in the scapula. This shallowdepression is known as the glenoid fossa. Six muscles extend between thehumerus and scapula and actuate the glenohumeral joint. These sixmuscles include the deltoid, the teres major, and the four rotator cuffmuscles. The rotator cuff muscles are a complex of muscles. The musclesof the rotator cuff include the supraspinatus, the infraspinatus, thesubscapularis, and the teres minor. The centering and stabilizing rolesplayed by the rotator cuff muscles are critical to the proper functionof the shoulder. The rotator cuff muscles provide a wide variety ofmoments to rotate the humerus and to oppose unwanted components of thedeltoid and pectoral muscle forces.

The muscles of the rotator cuff arise from the scapula. The distaltendons of the rotator cuff muscles splay out and interdigitate to forma common continuous insertion on the humerus. The supraspinatus musclearises from the supraspinatus fossa of the posterior scapula, passesbeneath the acromion and the acromioclavicular joint, and attaches tothe superior aspect of the greater tuberosity. The mechanics of therotator cuff muscles are complex. The rotator cuff muscles rotate thehumerus with respect to the scapula, compress the humeral head into theglenoid fossa providing a critical stabilizing mechanism to the shoulder(known as concavity compression), and provide muscular balance. Thesupraspinatus and deltoid muscles are equally responsible for producingtorque about the shoulder joint in the functional planes of motion.

The rotator cuff muscles are critical elements of this shoulder musclebalance equation. The human shoulder has no affixed axis. In a specifiedposition, activation of a muscle creates a unique set of rotationalmoments. For example, the anterior deltoid can exert moments in forwardelevation, internal rotation, and cross-body movement. If forwardelevation is to occur without rotation, the cross-body and internalrotation moments of this muscle must be neutralized by other muscles,such as the posterior deltoid and infraspinatus. The timing andmagnitude of these balancing muscle effects must be preciselycoordinated to avoid unwanted directions of humeral motion. Thus thesimplified view of muscles as isolated motors, or as members of forcecouples must give way to an understanding that all shoulder musclesfunction together in a precisely coordinated way—opposing musclescanceling out undesired elements leaving only the net torque necessaryto produce the desired action. Injury to any of these soft tissues cangreatly inhibit ranges and types of motion of the arm.

With its complexity, range of motion and extensive use, a common softtissue injury is damage to the rotator cuff or rotator cuff tendons.Damage to the rotator cuff is a potentially serious medical conditionthat may occur during hyperextension, from an acute traumatic tear orfrom overuse of the joint. With its critical role in abduction,rotational strength and torque production, the most common injuryassociated with the rotator cuff region is a strain or tear involvingthe supraspinatus tendon. A tear at the insertion site of the tendonwith the humerus, may result in the detachment of the tendon from thebone. This detachment may be partial or full, depending upon theseverity of the injury or damage. Additionally, the strain or tear canoccur within the tendon itself. Injuries to the supraspinatus tendon andcurrent modalities for treatment are defined by the type and degree oftear. The first type of tear is a full thickness tear, which as the termindicates is a tear that extends through the thickness of thesupraspinatus tendon regardless of whether it is completely tornlaterally. The second type of tear is a partial thickness tear which isfurther classified based on how much of the thickness is torn, whetherit is greater or less than about 50% of the thickness.

The accepted treatment for a full thickness tear or a partial thicknesstear greater than 50% includes reconnecting the torn tendon via sutures.For the partial thickness tears greater than 50%, the tear is completedto a full thickness tear by cutting the tendon prior to reconnection. Incontrast to the treatment of a full thickness tear or a partialthickness tear of greater than 50%, the current standard treatment for apartial thickness tear less than 50% usually involves physical cessationfrom use of the tendon, i.e., rest. Specific exercises can also beprescribed to strengthen and loosen the shoulder area. In manyinstances, the shoulder does not heal and the partial thickness tear canbe the source of chronic pain and stiffness. Further, the pain andstiffness may cause restricted use of the limb which tends to result infurther degeneration or atrophy in the shoulder. Surgical interventionmay be required for a partial thickness tear of less than 50%, however,current treatment interventions do not include repair of the tendon, andrather the surgical procedure is directed to arthroscopic removal ofbone to relieve points of impingement or create a larger tunnel betweenthe tendon and bone that is believed to be causing tendon damage. Aspart of the treatment, degenerated tendon may also be removed using adebridement procedure in which tendon material is ablated. Again, thetendon partial thickness tear is not repaired. Several authors havereported satisfactory early post operative results from theseprocedures, but over time recurrent symptoms have been noted. In theevent of recurrent symptoms, many times a patient will “live with thepain”. This may result in less use of the arm and shoulder which causesfurther degeneration of the tendon and may lead to more extensivedamage. A tendon repair would then need to be done in a later procedureif the prescribed treatment for the partial tear was unsuccessful inrelieving pain and stiffness or over time the tear propagated throughinjury or degeneration to a full thickness tear or a partial thicknesstear greater than 50% with attendant pain and debilitation. A subsequentlater procedure would include the more drastic procedure of completingthe tear to full thickness and suturing the ends of the tendon backtogether. This procedure requires extensive rehabilitation, hasrelatively high failure rates and subjects the patient who firstpresented and was treated with a partial thickness tear less than 50% toa second surgical procedure.

As described above, adequate treatments do not currently exist forrepairing a partial thickness tear of less than 50% in the supraspinatustendon. Current procedures attempt to alleviate impingement or make roomfor movement of the tendon to prevent further damage and relievediscomfort but do not repair or strengthen the tendon. Use of the stilldamaged tendon can lead to further damage or injury. Prior damage mayresult in degeneration that requires a second more drastic procedure torepair the tendon. Further, if the prior procedure was only partiallysuccessful in relieving pain and discomfort, a response may be to usethe shoulder less which leads to degeneration and increased likelihoodof further injury along with the need for more drastic surgery. Further,it would be beneficial to be able to treat partial thickness tearsgreater than 50% without cutting the untorn portion of the tendon tocomplete the tear before suturing back together. There is a large needfor surgical techniques and systems to treat partial thickness tears andprevent future tendon damage by strengthening or repairing the nativetendon having the partial thickness tear.

SUMMARY OF THE INVENTION

Some aspects of the present disclosure are directed to a fastener orstaple that can be used to attach an implant to bone. According to otheraspects, the staple or fastener can be included in a kit or system thatalso can include a staple delivery device and a pilot hole formingtrocar assembly. The trocar assembly is used to create pilot holes andretain instrument position with respect to those pilot holes for stapleinsertion. The staple delivery device can carry the staple into thepilot holes and release the staple in engagement with bone to retain theimplant in position.

The fastener or staple can also include, in some embodiments, a firstarm having a proximal end and a distal end, a second arm having aproximal end and a distal end, and a bridge connecting the first arm andsecond arm, wherein each of the first and second arms include a trunkportion extending over at least a portion of the length thereof. Eachtrunk can have a cavity therein and an aperture through a wall of eachtrunk to the cavity. In some embodiments, each of the cavities is alumen defined by a wall of each trunk having an inner surface definingthe lumen extending along a longitudinal axis with the apertureextending through this wall.

Each trunk can also include a claw disposed in each cavity of each trunkwherein each of the claws is moveable from a first retracted positionfor delivery of the staple to a second deployed position having aportion of the claw extending through the aperture in active engagementwith bone when implanted therein. Further each of the claws can includea head, the head including an anterior edge opposite a posterior edge, atail of the first claw abutting the posterior edge of the head, whereinthe head of each claw is disposed completely within the cavity of thetrunk in the delivery position.

Each claw can extend across the lumen of its respective trunk with theanterior edge of the head extending into the aperture and the tailextending through the aperture when the staple is in the deployedconfiguration. The head can be shaped and dimensioned such that cammingforces applied to the wall by the anterior edge of the head as the clawmoves between the delivery position and the deployed position urge aportion of the wall toward an elastically deflected shape.

Each head of each claw can have a major axis and a minor axis that isperpendicular to the major axis, the head having a length measured alongthe major axis and a width measured along the minor axis, the lengthbeing greater than the width. Further, the length of the head can begreater than a diameter of the lumen and the width of the head can beless than the diameter of the lumen. The major axis of the head can begenerally parallel to the longitudinal axis of the lumen when each clawis in the delivery position and the major axis of the head can extend ina direction transverse to the longitudinal axis of the lumen when eachclaw is in the deployed position. The minor axis of the head can extendin a direction transverse to the longitudinal axis of the lumen wheneach claw is in the delivery position and the minor axis of the head canbe generally parallel to the longitudinal axis of the lumen when eachclaw is in the deployed position.

In some embodiments, the fastener includes a pull member releasablyengaging each of the claws to move the claw from the first to the secondposition. The pull member can be a rod releasably connected to a slot ornotch in each claw. Alternatively, the pull member can be a sutureextending through a hole defined by each claw such that the suture canbe disconnected from the first claw by pulling one end of the suturethrough the hole.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view in partial cross section illustrating anexemplary tissue fastener or staple in accordance with the presentdisclosure as deployed in bone;

FIGS. 2A and 2B are alternative perspective views of the tissue fasteneror staple of FIG. 1 illustrating other features in accordance with thepresent disclosure;

FIGS. 3A-3E are schematic perspective views of the operable componentsof the exemplary tissue fastener prior to deployment in boneillustrating a projection deployment member;

FIGS. 4A-4B are partial cross sectional views of the fastener of FIG. 1depicting a projection in a first retracted state and a second deployedor extended state, respectively;

FIGS. 5A-5B are alternative perspective views of another exemplarytissue fastener of the present disclosure;

FIGS. 6A-6B are partial cross sectional views of the fastener of FIGS.5A-5B depicting a projection in a first retracted state and a seconddeployed or extended state, respectively;

FIGS. 7A-7B are alternative views of a tissue retention member inaccordance with the present disclosure;

FIGS. 8A-8F are a combination of partial cross sectional views andpartial top views depicting the deployment of a tissue retention member;

FIGS. 9A-9B are perspective views of a tissue fastener having a tissueretention member in a retracted and a deployed position;

FIG. 10 is a stylized anterior view of a shoulder including a humerusand a scapula;

FIG. 11 is a stylized of a shoulder depicting the head of the humerusshown mating with the glenoid fossa of the scapula at a glenohumeraljoint and a sheet-like material is affixed to the tendon;

FIG. 12 is a stylized perspective view showing a portion of the body ofa human patient divided into quadrants by planes for descriptivepurposes herein;

FIG. 13 is a stylized perspective view illustrating an exemplaryprocedure for arthroscopic treatment of a shoulder of a patient inaccordance with one embodiment of the disclosure;

FIG. 14 is a stylized perspective view of a shoulder including asupraspinatus having a distal tendon with a sheet-like material affixedthereto;

FIG. 15A is a simplified perspective view of a tissue fastener or stapledelivery device in accordance with the present disclosure;

FIG. 15B is a simplified perspective view of a trocar assembly,including a trocar disposed within a guide sheath assembly for creatingpilot holes and retaining the sheath within the formed pilot holes fordelivery of a tissue fastener or staple by a device such as thatdepicted in FIG. 10A;

FIG. 16A is a perspective view of the sheath assembly of FIG. 15B withthe trocar removed;

FIG. 16B is a perspective view of the trocar of FIG. 15B as removed fromthe sheath assembly;

FIG. 16C is a perspective view of one pilot hole position retentionmember which is positioned in a distal portion of the sheath assembly inone embodiment of the present disclosure;

FIGS. 17A-17B are partial perspective views of the distal portion of astaple delivery device illustrating deployment of tissue retentionmembers while holding the staple in a desired position;

FIG. 18A is simplified perspective view of a shoulder having an implantaffixed to the tendon and depicting the first step in a method ofdelivering fasteners to affix the implant to bone of the humeral head inaccordance with one method of the disclosure;

FIG. 18B is a simplified plan view of the distal portion of the trocarassembly as positioned to create pilot holes for affixing the implant tobone in a further step of a method of the disclosure;

FIG. 18C depicts the trocar assembly of FIG. 18B as inserted into thebone to form pilot holes in accordance with a method of the disclosure;

FIG. 18D depicts the trocar assembly with the trocar portion removed andthe remaining sheath assembly retaining its position in the pilot holesformed;

FIG. 18E depicts insertion of a fastener or staple into the formedpilots holes through the sheath assembly in accordance with a method ofthe disclosure; and,

FIG. 18F illustrates a fastener or staple as inserted in accordance witha method of the disclosure.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of theinvention.

FIG. 1 is a perspective view illustrating an exemplary staple 100 inaccordance with the present detailed description. The staple is depicteddeployed in bone with the bone shown in partial cross section so thatfeatures of the staple can be viewed. In particular, the staple 100includes a bridge 104 that connects two longitudinally extending arms102 (only one arm 102A is visible in FIG. 1). At least a portion of eacharm includes a trunk 120 which may extend for the full length of the armor only a portion of the length. If the trunk 120 extends for only aportion of the arm, then a non-trunk portion of the arm will connect thetrunk to the bridge.

The staple is illustrated deployed in bone having a cortical layer 375and a cancellous portion 376. The staple is deployed in pilot holes 309,as later described herein. Further, each trunk includes a claw portion130 that is moveable from a retracted or stowed position within thetrunk 120 to a deployed or extended position as shown in FIG. 1. In theextended position, the claw 130 interacts with the bone providingpullout strength when force is applied to the bridge, such as forceapplied to an implant 50 as illustrated.

FIG. 2A and FIG. 2B are perspective views illustrating the staple 100 ofFIG. 1 in alternative views, with the staple rotated 180 degrees in FIG.2B from FIG. 2A so that in combination both sides of the staple areviewed. FIG. 2A and FIG. 2B may be collectively referred to as FIG. 2.Staple 100 comprises a first arm 102A and a second arm 102B. A bridge104 of staple 100 can be seen extending between the proximal end offirst arm 102A and the proximal end of second arm 102B. A proximaldirection P and a distal direction D are illustrated with arrows in FIG.2.

In the embodiment of FIG. 2, each arm 102A, 102B include a first trunk120A and a second trunk 120B, respectively. As illustrated the trunksextend for substantially the entire length of the arms 102A, 102B.However, this length may be varied in alternative embodiments. Firsttrunk 120A of staple 100 comprises a first wall defining a first lumen124A. A first claw 130A is at least partially disposed in first lumen124A. The first trunk 120A also defines a first aperture 128A thatfluidly communicates with first lumen 124A. In the embodiment of FIG. 2,first aperture 128A is disposed on a first side 108A of staple 100 shownas the top in FIG. 2A. First side 108A is generally opposite a secondside 108B of staple 100 which is shown as the top in FIG. 2B. First claw130A can be seen fully retracted or stowed within first aperture 128A.

Second trunk 120B of staple 100 comprises a second wall that defines asecond lumen 124B. Second claw 130B is disposed in second lumen 124B inthe embodiment of FIG. 2. The second trunk 120B also defines a secondaperture 128B that fluidly communicates with second lumen 124B. Thesecond aperture 128B is disposed on the first side 108A of staple 100.Second claw 130B can be seen fully retracted or stowed in secondaperture 128B.

In the embodiment of FIG. 2, first lumen 124A extends along a firstlongitudinal axis 126A and second lumen 124B extends along a secondlongitudinal axis 126B. When first claw 130A is in the deployedposition, a distal portion of first claw 130A extends in a directiontransverse to first longitudinal axis 126A. Similarly, second claw 130Bextends in a direction transverse to second longitudinal axis 126B whensecond claw 130B is in the deployed position. When first claw 130Aextends in a direction transverse to first longitudinal axis 126A andsecond claw 130B extends in a direction transverse to secondlongitudinal axis 126B, the claws may act to retain staple 100 in atissue.

As illustrated in FIG. 2A, each aperture 128 is defined by a pluralityof edge surfaces of the wall defining that aperture. More particularly,in the exemplary embodiment of FIG. 2A, each aperture 128 is defined bya proximal edge surface 146B, a distal edge surface 146A, and two sideedge surfaces 146C and 146D.

FIG. 3A is a perspective view illustrating an exemplary assembly inaccordance with this detailed description. FIGS. 3B-3D are additionalperspective views showing the individual components of the assembly ofFIG. 3A in an exploded state. FIG. 3A-3D may be collectively referred toas FIG. 3. Staple 100 of FIG. 3 comprises a first arm 102A and a secondarm 102B. A bridge 104 of staple 100 can be seen extending between theproximal end of first arm 102A and the proximal end of second arm 102B.

First trunk 120A of staple 100 comprises a first wall defining a firstlumen 124A. A first claw 130A is partially disposed in first lumen 124Ain the embodiment of FIG. 3A. First trunk 120A also defines a firstaperture 128A that fluidly communicates with first lumen 124A. A portionof first claw 130A be seen extending beyond first aperture 128A in FIG.3A. Second trunk 120B also defines a second aperture 128B that fluidlycommunicates with second lumen 124B. A portion of second claw 130B canbe seen extending beyond second aperture 128B in FIG. 3A.

In FIG. 3A, a first pull member 160A can be seen extending into firstlumen 124A of first trunk 120A. In the embodiment of FIG. 3, first pullmember 160A comprises a first control rod 170A that is slidably disposedin first lumen 124A of first trunk 120A. First control rod 170A andfirst claw 130A engage each other to form a mechanically interlocking,but releasable connection. The connection between first control rod 170Aand first claw 130A is configured such that a proximally directed forceapplied to first control rod 170A is transferred to first claw 130A tourge movement of first claw 130A between a delivery or retractedposition and a deployed position. In the exemplary embodiment of FIG. 3,first control rod 170 includes a tab 164 that is received in a slot ornotch 166 defined by first claw 130A.

In FIG. 3A, a second pull 160B can be seen extending into second lumen124B of second trunk 120B. In the embodiment of FIG. 3, second pull 160Bcomprises a second control rod 170B that is slidably disposed in secondlumen 124B of second trunk 120B. Second control rod 170B and second claw130B engage each other to form a mechanically interlocking, butreleasable connection. The connection between second control rod 170Band second claw 130B is configured such that a proximally directed forceapplied to second control rod 170B is transferred to second claw 130B tourge movement of second claw 130B between a delivery or retractedposition and a deployed position. In the exemplary embodiment of FIG. 3,second control rod 170 includes a tab 164 that is received in a notch166 defined by second claw 130B. The proximal end of second pull 160B isdepicted as coupled to the proximal end of first pull 160A so thatproximally directed forces may be simultaneously applied to first claw130A and second claw 130B.

FIG. 3E is a perspective view of an exemplary claw 130 in accordancewith this detailed description. In the embodiment of FIG. 3E, claw 130comprises a body 133 including an upper surface 138 and a lower surface140. Upper surface 138 and lower surface 140 are on opposite sides ofclaw 130. In the embodiment of FIG. 3E, body 133 extends along acurvilinear axis 132. Upper surface 138 and lower surface 140 areseparated by the height of body 133. Body 133 has a tapering shape suchthat the height of body 133 changes along curvilinear axis 132. In someuseful embodiments, the height of body 133 is selected so that aninterference fit is formed between claw 130 and an aperture defined by atrunk when claw 130 is disposed in a deployed position (as illustratedin the previous Figure).

The proximal end of first claw 130A comprises a knife edge 168. In someuseful embodiments, the shape of knife edge 168 is sufficiently sharp sothat knife edge 168 cuts into at least a portion of the thickness orthrough the inner surface of a wall of trunk 120 when claw 130 isassuming a deployed position relative to a trunk to retain the deployedposition. In the embodiment of FIG. 3E, upper surface 138 of first claw130A includes a convex surface 142. Also in the embodiment of FIG. 3E,lower surface 140 of first claw 130A comprises a concave surface 144.Body 133 of claw 130 defines a notch 166. In some useful embodiments,notch 166 is dimensioned to receive a tab, for example, the tabillustrated in the previous Figure.

FIG. 4A and FIG. 4B are cross-sectional views illustrating an exemplarystaple 100 in accordance with this detailed description. Staple 100 ofFIG. 4 includes first trunk assembly 103A. First trunk assembly 103Aincludes a first claw 130A that is partially disposed in a first lumen124A defined by a first trunk 120A. First claw 130A is disposed in adelivery or retracted position in the embodiment of FIG. 4A. In theembodiment of FIG. 4B, however, first claw 130A is disposed in adeployed position. Methods in accordance with this detailed descriptionmay include the step of moving a claw from a delivery or retractedposition (e.g., the delivery position of FIG. 4A) to a deployed position(e.g., the deployed position of FIG. 4B).

Staple 100 includes first trunk 120A and a second trunk (not visible inFIG. 4). A bridge 104 of staple 100 extends from the proximal end offirst arm 102A to the proximal end of the second arm. First trunk 120Aof staple 100 includes a wall 120 having an inner surface 122 definingfirst lumen 124A. In the embodiment of FIG. 4, first lumen 124A extendsalong a first longitudinal axis 126A. Wall 120 of first trunk 120A alsodefines a first aperture 128A that fluidly communicates with first lumen124A. In the embodiment of FIG. 4, first aperture 128A is disposed on afirst side 108A of staple 100. Staple 100 also includes a second side108B, generally opposite first side 108A.

First claw 130A can be seen extending beyond first aperture 128A by afirst distance in FIG. 4A. First claw 130A can be seen extending beyondfirst aperture 128A by a second distance in FIG. 4B with the seconddistance greater than the first distance. The position of first claw130A in FIG. 4A may be referred to as a delivery position and theposition of first claw 130A in FIG. 4B may be referred to as a deployedposition. When first claw 130A is in the deployed position, a distalportion of first claw 130 extends in a direction that is generallytransverse to first longitudinal axis 126A. When first claw 130 extendsin a direction transverse to first longitudinal axis 126A first claw130A may act to retain first trunk 120A in a tissue.

In the embodiment of FIG. 4, first claw 130A comprises a body 133extending along a curvilinear axis 132. Body 133 of first claw 130Aincludes an upper surface 138 and lower surface 140 that are separatedby the height of body 133. Upper surface 138 of first claw 130A includesa convex surface 142. Lower surface 140 of first claw 130A includes aconcave surface 144. In the embodiment of FIG. 4, body 133 has atapering shape such that the height of body 133 changes alongcurvilinear axis 132. In FIG. 4B, upper surface 138 of body 150 can beseen contacting a proximal edge surface 146B and lower surface 140 ofbody 150 can be seen contacting distal edge surface 146A. Proximal edgesurface 146B and distal edge surface 146A partially define a firstaperture 128A. First aperture 128A is defined by a plurality of edgesurfaces of wall 120. More particularly, in the exemplary embodiment ofFIG. 4, first aperture 128A is defined by proximal edge surface 146B,distal edge surface 146A, and two side edge surfaces. Only one side edgesurface 146D is visible in the cross-sectional view of FIG. 4. Theheight of first claw 130A is selected so that an interference fit isformed between first claw 130A and first trunk 102A when first claw isdisposed in the locked position of FIG. 4B.

In FIG. 4, a first pull member 160A can be seen extending into lumen 124of first trunk 120A. The first pull member 160A includes a control rod170 that is slidably disposed in lumen 124 of first trunk 120A. Controlrod 170 and first claw 130A engage each other to form a mechanicallyinterlocking but releasable connection 162. Connection 162 is configuredsuch that a proximally directed force applied to control rod 170 istransferred to first claw 130A to urge movement of first claw 130Abetween the delivery position of FIG. 4A and the deployed position ofFIG. 4B. The proximal direction P and a distal direction D areillustrated with arrows in FIG. 4. In the exemplary embodiment of FIG.4, control rod 170 includes a tab 164 that is received in a notch 166defined by first claw 130A.

In the embodiment of FIG. 4, the height of body 133 varies alongcurvilinear axis 132 such that, when first claw 130A reaches thedeployed position of FIG. 4B, an intermediate portion of first claw 130Abecomes wedged between proximal edge surface 146B and distal edgesurface 146A, forming an interference fit between first claw 130A andfirst trunk 120A. In the embodiment of FIG. 4, the proximally directedforce applied to first claw 130A by first pull member 160 is offset fromproximal edge 146B such that the proximally directed force causes firstclaw 130A to rotate as upper surface 138 slides along proximal edge146B. The proximal end of first claw 130A comprises a knife edge 168. Insome useful embodiments, knife edge 168 is sufficiently sharp and madeof a material sufficiently hard to cut into at least a portion of thethickness of the material of wall 120. The penetrating engagementbetween knife edge 168 and wall 120 may help retain first claw 130A inthe deployed position shown in FIG. 4B.

FIG. 5A and FIG. 5B are perspective views illustrating another exemplarystaple 400 in accordance with the present detailed description. FIGS. 5Aand 5B may be collectively referred to as FIG. 5. With reference to FIG.5, it will be appreciated that staple 400 may assume variousorientations without deviating from the spirit and scope of thisdetailed description. Reference directions are illustrated using arrowsin to identify a proximal direction P and a distal direction D.

Staple 400 of FIG. 5 can included a first arm 402A, a second arm 402Band a bridge 404. First arm 402A has a proximal end 406A and a distalend 407A. Second arm 402B has a proximal end 406B and a distal end 407B.In the embodiment of FIG. 5, a first end of bridge 404 abuts theproximal end 406A of first arm 402A and a second end of bridge 404 abutsthe proximal end 406B of second arm 402B. Bridge 404 can be seenextending between proximal end 406A of first arm 402A and proximal end406B of second arm 402B. In the embodiment of FIG. 5, each arm 402A,402B include a first trunk 420A and a second trunk 420B, respectively.As illustrated the trunks extend for substantially the entire length ofthe arms 402A, 402B. However, this length may be varied in alternativeembodiments.

In the embodiment of FIG. 5, staple 400 includes a plurality ofapertures 428. These apertures 428 include a first aperture 428A, asecond aperture 428B, a third aperture 428C, and a fourth aperture 428D.First aperture 428A and second aperture 428B extend through a first wallof first trunk 420A. Third aperture 428C and fourth aperture 428D extendthrough a second wall of second trunk 420B. Each aperture 328 is definedby a plurality of edge surfaces of the wall defining that aperture. Moreparticularly, in the exemplary embodiment of FIG. 5, each aperture 328is defined by a proximal edge surface 446B, a distal edge surface 446A,and two side edge surfaces 446C and 446D.

First wall of first trunk 420A has an inner surface 422A defining afirst lumen 424A. First lumen 424A extends along a first longitudinalaxis 426A. First wall of first trunk 420A also defines first aperture428A and second aperture 428B. First aperture 428A is disposed on afirst side 408A of staple 400 and second aperture 428B is disposed on asecond side 408B of staple 400. First aperture 428A and a secondaperture 428B both fluidly communicate with first lumen 424A. In FIG. 5,first wall of first trunk 420A is shown assuming a relaxed shape inwhich no external forces are acting on the first wall. With reference toFIG. 5, it will be appreciated that the relaxed shape of the first wallhas a generally circular profile in a plane orthogonal to firstlongitudinal axis 426A when the first wall is free to assume the relaxedshape.

Second wall of second trunk 420B has an inner surface 422B that definesa first lumen 424A. Second lumen 424B extends along a secondlongitudinal axis 426B. Second wall 420B of second trunk 402B alsodefines third aperture 428C and fourth aperture 428D. Third aperture428C and a fourth aperture 428D both fluidly communicate with firstlumen 424A. Third aperture 428C is disposed on first side 408A of staple400 and second aperture 428B is disposed on second side 408B of staple400. In FIG. 5, the second wall of second trunk 420B is shown assuming arelaxed shape in which no external forces are acting on the second wall.As discussed above, the second wall has a generally circular profile ina plane orthogonal to second longitudinal axis 426B when second wall isfree to assume the relaxed shape.

FIG. 6A and FIG. 6B are cross-sectional views illustrating the internalportion of the trunk 420A of a staple 400 as described above. The trunk420 includes a trunk assembly 403A which mechanism acts to retain thestaple in tissue. The first trunk assembly 403A includes a first claw430A that is partially disposed in a first lumen 424A defined by a firsttrunk 420A. First claw 430A is disposed in a delivery position in theembodiment of FIG. 6A. In the embodiment of FIG. 6B, however, first claw430A is disposed in a deployed position. First claw 430A is disposed inthe delivery position of FIG. 6A when first trunk assembly 403A is in adelivery configuration. First claw 430A is disposed in the deployedposition of FIG. 6B when first trunk assembly 403A is in a deployedconfiguration. In the exemplary embodiment of FIG. 6, first trunkassembly 403A is configured to transition between and be stable in onlythe delivery configuration of FIG. 6A and the deployed configuration ofFIG. 6B.

First trunk 420A of staple 400 includes a first wall having a firstinner surface 422A defining a first lumen 424A. In the embodiment ofFIG. 6, first lumen 424A extends along a first longitudinal axis 426A. Adiameter D of first lumen 424A is illustrated using dimension lines inFIG. 6B. The first wall of first trunk 402A defines first aperture 428Aand second aperture 428B in the embodiment of FIG. 6. In someembodiments, a center of first aperture 428A and a center of secondaperture 428B are generally aligned with each other along opposite sidesof longitudinal axis 426A. First aperture 428A is disposed on a firstside 408A of staple 400 and second aperture 428B is disposed on a secondside 408B of staple 400. With reference to FIG. 6, it will beappreciated that first side 408A and second side 408B are oppositesides. First aperture 428A and a second aperture 428B both fluidlycommunicate with first lumen 424A.

First claw 430A can be seen extending beyond first aperture 428A by afirst distance in FIG. 6A. First claw 430A can be seen extending beyondfirst aperture 428A by a second distance in FIG. 6B. With reference toFIG. 6, it will be appreciated that the second distance is greater thanthe first distance. The position of first claw 430A in FIG. 6A may bereferred to as a delivery position of first claw 430A and in FIG. 6B maybe referred to as a deployed position. When first claw 430A is in thedeployed position, a distal portion of first claw 430A extends in adirection that is generally transverse to first longitudinal axis 426A.When first claw 430A extends in a direction transverse to firstlongitudinal axis 426A first claw 430A may act to retain first trunk 420in a tissue.

In the embodiment of FIG. 6, first claw 430A comprises a head 452including an anterior edge 490 opposite a posterior edge 492. A tail 454of first claw 430A abuts posterior edge 492 of head 452. The first wallof first trunk 420A is shown assuming a relaxed shape in which noexternal forces are acting on the first wall. In the exemplaryembodiment of FIG. 6, the relaxed shape of the first wall has agenerally circular profile in a plane orthogonal to first longitudinalaxis 426A when the first wall is free to assume the relaxed shape. Inthe embodiment of FIG. 6, head 452 is shaped and dimensioned such thatcamming forces applied to the first wall of first trunk 420A by anterioredge 490 of head 452 as first claw 430A moves between the deliveryposition of FIG. 6A and the deployed position of FIG. 6B will urge aportion of the first wall toward an elastically deflected shape that ismore elliptical than the relaxed shape of the wall. The material of thefirst wall can have a level of elasticity such that the first wallreturns to the relaxed shape when first claw 430A reaches the deployedposition of FIG. 6B. The plurality of edge surfaces that define firstaperture 428A and second aperture 428B create a physical barrierpreventing first claw 430A from moving out of the deployed position.

With reference to FIG. 6B, it will be appreciated that, when first claw430A is disposed in the deployed position, first claw 430A extendsacross first lumen 424A with anterior edge 490 extending into secondaperture 428B and tail 454 extending through first aperture 428A. Withreference to FIG. 6A, it will be appreciated that, when first claw 430Ais disposed in the delivery position, head 452 of first claw 430A isdisposed completely within first lumen 424A.

In FIG. 6, a pull member 460 can be seen extending into first lumen 424Aof first trunk 420A. Pull member 460 can include a suture 480 having afirst end 482A and a second end 482B. Suture 480 and first claw 430Aengage each other to form a connection 462. Connection 462 is configuredsuch that a proximally directed force applied to suture 480 istransferred to first claw 430A to urge movement of first claw 430Abetween the delivery position of FIG. 6A and the deployed position ofFIG. 6B. The proximal direction P and a distal direction D areillustrated with arrows in FIG. 6. In the exemplary embodiment of FIG.6, first claw 430A defines a hole 484. A portion of suture 480 extendingbetween first end 482A and second end 482B is threaded through hole 484defined by first claw 430.

Methods in accordance with this detailed description may include thestep of moving a claw from a delivery position (e.g., the deliveryposition of FIG. 6A) to a deployed position (e.g., the deployed positionof FIG. 6B). In the embodiment of FIG. 6, first claw 430A can be movedfrom the delivery position of FIG. 6A to the deployed position of FIG.6B by applying a proximally directed pulling force on first end 482A andsecond end 482B of suture 480. After first claw 430A has been deployed,suture 480 may be removed by pulling one of first end 482A and secondend 482B through hole 484 defined by first claw 430A.

FIG. 7A is a perspective view of an exemplary claw 430 in accordancewith this detailed description. FIG. 7B is a plan view of claw 430 shownin FIG. 7A. FIG. 7A and FIG. 7B may be collectively referred to as FIG.7. In the embodiment of FIG. 7, claw 430 comprises a head 452 includingan anterior edge 490 opposite a posterior edge 492. A tail 454 of claw430 abuts posterior edge 492 of head 452 in the embodiment of FIG. 7.Head 452 of claw 430 defines a hole 484. Head 452 is shaped anddimensioned such that camming forces applied to a wall (e.g., first wallshown in FIG. 6) by anterior edge 490 of head 452 as claw 430 movesbetween a delivery position and a deployed position will urge a portionof the wall toward an elastically deflected shape that is moreelliptical than the relaxed shape of the wall. Head 450 of claw 430 hasa major axis 456 and a minor axis 458. As illustrated in FIG. 7B, head450 has a length L measured in a direction generally parallel to majoraxis 456. A width W of head 450 is also illustrated in FIG. 7B. Withreference to FIG. 7B, it will be appreciated that width W is measured ina direction that is generally parallel to minor axis 458. In theexemplary embodiment of FIG. 7, length L is greater than width W.

Referring again to FIG. 6, it will be appreciated that width W of head652 is less than or about equal to the diameter D of first lumen 424A.In the embodiment of FIG. 6, length L of head 450 is greater than thediameter D of first lumen 424A. With reference to FIG. 6A, it will beappreciated that the major axis of head 452 is generally parallel tofirst longitudinal axis 426A of first lumen 424A when first claw 430A isin the delivery position. The minor axis of head 452 extends in adirection transverse to first longitudinal axis 426A of first lumen 424Awhen first claw 430A is in the delivery position of FIG. 6A. Withreference to FIG. 6B, it will be appreciated that the major axis of head452 is generally transverse to first longitudinal axis 426A of firstlumen 424A when first claw 430A is in the deployed position. The minoraxis of head 452 extends in a direction generally parallel to firstlongitudinal axis 426A of first lumen 424A when first claw 430A is inthe deployed position of FIG. 6B.

FIG. 8A, FIG. 8B and FIG. 8C form a sequence of stylized front planviews illustrating an exemplary method in accordance with this detaileddescription. FIG. 8D, FIG. 8E and FIG. 8F form a sequence stylized topplan views further illustrating the method shown in FIG. 8A, FIG. 8B andFIG. 8C.

FIG. 8A and FIG. 8D are plan views showing a first trunk assembly 403A.In the exemplary embodiment of FIG. 8A and FIG. 8D, first trunk assembly403A is in a delivery configuration. First trunk assembly 403A includesa first claw 430A that is partially disposed in a first lumen 424Adefined by a first wall 420A of a first trunk 402A. First lumen 424Aextends along a first longitudinal axis 426A. First claw 430A isdisposed in a delivery position in the embodiment of FIG. 8A and FIG.8D. With reference to FIG. 8A, it will be appreciated that a head offirst claw 430A is disposed completely within lumen 424A when first claw430A is in the delivery position. In FIG. 8A and FIG. 8D, first wall offirst trunk 302A is shown assuming a relaxed shape in which no externalforces are acting on first wall. With reference to FIG. 8D, it will beappreciated that the relaxed shape of first trunk 420A has a generallycircular profile in a plane orthogonal to first longitudinal axis 426Awhen first wall of the first trunk 420A is free to assume the relaxedshape.

FIG. 8B and FIG. 8E are additional plan views showing first trunkassembly 403A. In the exemplary embodiment of FIG. 8B and FIG. 8E, firsttrunk assembly 403A is in the process of transitioning between thedelivery configuration of FIG. 8A and a deployed configuration. Thedeployed configuration is illustrated in FIG. 8C and FIG. 8F. In theembodiment of FIG. 8B, a head of first claw 430A is shaped anddimensioned such that camming forces applied to first wall of firsttrunk 420A by an anterior edge of first claw 430A as the first clawmoves between the delivery position of FIG. 8A and the deployed positionof FIG. 8C will urge a portion of first wall 420A toward an elasticallydeflected shape that is more elliptical than the relaxed shape of thewall. In the exemplary embodiment of FIG. 8, the material of first trunk420A has a level of elasticity such that first wall returns to therelaxed shape when first claw 430A reaches the deployed position of FIG.8C. In the embodiment of FIG. 8B and FIG. 8E, the camming forces actingon first wall have produced bulges 494 in first trunk 420A.

FIG. 8C and FIG. 8F are plan views showing first trunk assembly 403A ina deployed configuration. First trunk assembly 403A includes a firstclaw 430A that is partially disposed in a first lumen 424A defined by afirst trunk 402A. First claw 430A is disposed in a deployed position inthe embodiment of FIG. 8C and FIG. 8F. In FIG. 8F, a first wall of firsttrunk 420A is shown assuming a relaxed shape in which no external forcesare acting on first wall of first trunk 420A. In the exemplaryembodiment of FIG. 8F, the relaxed shape of first wall of first trunk420A has a generally circular profile in a plane orthogonal to firstlongitudinal axis 426A when first wall 420A is free to assume therelaxed shape.

In FIG. 8C, a tail portion of first claw 430A can be seen extendingthrough a first aperture 428A defined by first wall of first trunk 420A.An anterior edge of the head portion of first claw 430A can be seenextending into a second aperture 428B defined by first wall of firsttrunk 420A in FIG. 8C. In the embodiment of FIG. 8C, the plurality ofedge surfaces defining the apertures create a physical barrierpreventing first claw 430A from moving out of the deployed position.

FIGS. 9A and 9B provide perspective views of a staple 500 of the presentdisclosure. Each staple can include a first and second arm 502A, 502B,each having a proximal end attached to a bridge 504 extendingtherebetween. Each arm includes a trunk 520A, 520B, generally of largercross section than the bridge 504. In some embodiments, the trunk 520extends the entire length of the arm 502 and has a proximal end fixed tothe bridge 504. Alternatively, the arms can include a trunk andnon-trunk portion, with the non-trunk portion extending between theproximal end of the trunk and the bridge.

Each trunk 520 has a lumen or cavity 524 therein in which is disposed aclaw 530. Each trunk further includes at least one aperture 528 througha side wall thereof. The claw 530 is sized and shaped to fit within thelumen or cavity 524 and move between a first retracted or deliveryposition (FIG. 9A) and a second extended or deployed position (FIG. 9B)wherein at least a portion of the claw 530 interacts with bone to retainthe staple 500 in position at a treatment site.

Next referring to FIG. 10, an exemplary use or application of thestaples of the present disclosure is described. FIG. 10 is a stylizedanterior view of a patient 20. For purposes of illustration, a shoulder22 of patient 20 is shown in cross-section in FIG. 10. Shoulder 22includes a humerus 14 and a scapula 12. In FIG. 10, a head 24 of humerus14 can be seen mating with a glenoid fossa of scapula 12 at aglenohumeral joint. With reference to FIG. 10, it will be appreciatedthat the glenoid fossa comprises a shallow depression in scapula 12. Themovement of humerus 14 relative to scapula 12 is controlled by a numberof muscles including: the deltoid, the supraspinatus, the infraspinatus,the subscapularis, and the teres minor. For purposes of illustration,only the supraspinatus 26 is shown in FIG. 10.

With reference to FIG. 10, a distal tendon 28 of the supraspinatus 26meets humerus 14 at an insertion point. Scapula 12 of shoulder 22includes an acromium 32. In FIG. 10, a subacromial bursa 34 is shownextending between acromium 32 of scapula 12 and head 24 of humerus 14.Subacromial bursa 34 is shown overlaying supraspinatus 26 as well assupraspinatus tendon 28 and a portion of humerus 14. Subacromial bursa34 is one of the hundreds of bursae found the human body. Each bursacomprises a fluid filled sac. The presence of these bursae in the bodyreduces friction between bodily tissues.

The exemplary staples or fasteners described herein may be used to affixtendon repair implants to various target tissues. The shoulder depictedin FIG. 10 is one example where a tendon repair implant may be affixedto one or more bones associated with an articulating joint, such as theglenohumeral joint. Additionally, the tendon repair implant may beaffixed to one or more tendons to be treated. The tendons to be treatedmay be torn, partially torn, have internal micro-tears, be untorn,and/or be thinned due to age, injury or overuse. Applicants believe thatthe methods and apparatus of the present application and related devicesmay provide very beneficial therapeutic effect on a patient experiencingjoint pain believed to be caused by partial thickness tears and/orinternal microtears. By applying a tendon-repair implant early before afull tear or other injury develops, the implant may cause the tendon tothicken and/or at least partially repair itself, thereby avoiding moreextensive joint damage, pain, and the need for more extensive jointrepair surgery.

FIG. 11 is a stylized anterior view of a shoulder 22 including a humerus14 and a scapula 12. In FIG. 11, a head 24 of humerus 14 is shown matingwith a glenoid fossa of scapula 12 at a glenohumeral joint. Asupraspinatus 26 is also shown in FIG. 11. This muscle, along withothers, controls the movement of humerus 14 relative to scapula 12. Adistal tendon 28 of supraspinatus 26 meets humerus 14 at an insertionpoint 30.

As depicted in FIG. 11, distal tendon 28 includes a first damagedportion 36. A number of loose tendon fibers 40 in first damaged portion36 are visible in FIG. 11. First damaged portion 36 includes a firsttear 42 extending partially through distal tendon 28. First tear 42 maytherefore be referred to as a partial thickness tear. With reference toFIG. 11, first tear 42 begins on the side of distal tendon 28 facing thesubacromial bursa (shown in the previous Figure) and ends midway throughdistal tendon 28. Accordingly, first tear 42 may be referred to as abursal side tear.

With reference to FIG. 11, distal tendon 28 includes a second damagedportion 38 located near insertion point 30. As illustrated, seconddamaged portion 38 of distal tendon 28 has become frayed and a number ofloose tendon fibers 40 are visible. Second damaged portion 38 of distaltendon 28 includes second tear 44. Second tear 44 begins on the side ofdistal tendon 28 facing the center of the humeral head 24. Accordingly,second damaged portion 38 may be referred to as an articular side tear.

FIG. 11 illustrates a sheet-like implant 50 has been placed over thebursal side of distal tendon 28. The sheet-like implant 50 is affixed todistal tendon 28 by a plurality of tendon staples 51. Sheet-like implant50 is affixed to humerus 14 by a plurality of bone staples 100 inaccordance with designs of staples disclosed herein. Sheet-like implant50 extends over insertion point 30, first tear 42 and second tear 44.Some useful methods in accordance with this detailed description mayinclude placing a tendon repair implant on the bursal side of a tendonregardless of whether the tears being treated are on the bursal side,articular side or within the tendon. In some cases the exact locationand nature of the tears being treated may be unknown. A tendon repairimplant may be applied to the bursal side of a tendon to treat shoulderpain that is most likely caused by one or more partial thickness tearsin the tendon.

FIG. 12 is a stylized perspective view showing a portion of the body 82of a human patient 20. Body 82 includes a shoulder 22. In the exemplaryembodiment of FIG. 12, a plurality of cannulas are positioned to accessa treatment site within shoulder 22. In some cases, shoulder 22 may beinflated by pumping a continuous flow of saline through shoulder 22 tocreate a cavity proximate the treatment site. The cannulas shown in FIG.12 include a first cannula 80A, a second cannula 80B and a third cannula80C.

In FIG. 12, a sagital plane SP and a frontal plane FP are shownintersecting body 82. Sagital plane SP and frontal plane FP intersectone another at a medial axis MA of body 82. With reference to FIG. 12,sagital plane SP bisects body 82 into a right side 84 and a left side86. Also with reference to FIG. 12, frontal plane FP divides body 82into an anterior portion 92 and a posterior portion 88. Sagital plane SPand a frontal plane FP are generally perpendicular to one another. Theseplanes and portions are used to describe the procedures used inexemplary embodiments.

First cannula 80A is accessing a treatment site within shoulder 22 usinga lateral approach in which first cannula 80A pierces the outer surfaceof right side 84 of body 82. The term lateral approach could also beused to describe situations in which an instrument pierces the outersurface of left side 86 of body 82. Second cannula 80B is accessing atreatment site within shoulder 22 using a posterior approach in whichsecond cannula 80B pierces the outer surface of posterior portion 88 ofbody 82. Third cannula 80C is accessing a treatment site within shoulder22 using an anterior approach in which third cannula 80C pierces theouter surface of anterior portion 92 of body 82.

FIG. 13 is a stylized perspective view illustrating an exemplaryprocedure for treating a shoulder 22 of a patient 20. The procedureillustrated in FIG. 13 may include, for example, fixing tendon repairimplants to one or more tendons of shoulder 22. The tendons treated maybe torn, partially torn, have internal micro-tears, be untorn, and/or bethinned due to age, injury or overuse.

Shoulder 22 of FIG. 13 has been inflated to create a cavity therein. Afluid supply 52 is pumping a continuous flow of saline into the cavity.This flow of saline exits the cavity via a fluid drain 54. A camera 56provides images from inside the cavity. The images provided by camera 56may be viewed on a display 58.

Camera 56 may be used to visually inspect the tendons of shoulder 22 fordamage. A tendon repair implant in accordance with this disclosure maybe affixed to a bursal surface of the tendon regardless of whether thereare visible signs of tendon damage. Applicants believe that the methodsand apparatus of the present application and related devices may providevery beneficial therapeutic effect on a patient experiencing joint painbelieved to be caused by internal microtears, but having no clear signsof tendon tears. By applying a tendon repair implant early before a fulltear or other injury develops, the implant may cause the tendon tothicken and/or at least partially repair itself, thereby avoiding moreextensive joint damage, pain, and the need for more extensive jointrepair surgery.

An implant delivery system 60 can be seen extending from shoulder 22 inFIG. 13. Implant delivery system 60 is extending through a first cannula80A. In certain embodiments, first cannula 80A can access a treatmentsite within shoulder 22 using a lateral approach in which first cannula80A pierces the outer surface of a right side of the patient's body. Insome cases a physician may choose not to use a cannula in conjunctionwith implant delivery system 60. When that is the case, the implantdelivery system may be advanced through tissue. Implant delivery system60 comprises a sheath that is affixed to a handle. The sheath defines alumen and a distal opening fluidly communicating with the lumen. In theembodiment of FIG. 13, the distal opening of the sheath has been placedin fluid communication with the cavity created in shoulder 22.

A tendon repair implant is at least partially disposed in the lumendefined by the sheath of implant delivery system 60. Implant deliverysystem 60 can be used to place the tendon repair implant inside shoulder22. In some embodiments, the tendon repair implant is folded into acompact configuration when inside the lumen of the sheath. When this isthe case, implant delivery system 60 may be used to unfold the tendonrepair implant into an expanded shape. Additionally, implant deliverysystem 60 can be used to hold the tendon repair implant against thetendon.

The tendon repair implant may be affixed to the tendon while it is heldagainst the tendon by implant delivery system 60. Various attachmentelements may be used to fix the tendon-repair implant to the tendon.Examples of attachment elements that may be suitable in someapplications include sutures, tissue anchors, bone anchors, and staples.In the exemplary embodiment of FIG. 13, the shaft of a fixation tool 70is shown extending into shoulder 22. In one exemplary embodiment,fixation tool 70 is capable of fixing the tendon repair implant to thetendon and bone with one or more staples of the present disclosure whilethe tendon repair implant may held against the tendon by implantdelivery system 60.

FIG. 14 is a stylized perspective view of a shoulder 22 including asupraspinatus 26 having a distal tendon 28. With reference to FIG. 14, atendon repair implant 50 has been affixed to a surface of distal tendon28. Tendon repair implant 50 may comprise, for example, varioussheet-like structures without deviating from the spirit and scope of thepresent detailed description. In some useful embodiments, the sheet-likestructure may comprise a plurality of fibers. The fibers may beinterlinked with one another. When this is the case, the sheet-likestructure may comprise a plurality of apertures comprising theinterstitial spaces between fibers. Various processes may be used tointerlink the fibers with one another. Examples of processes that may besuitable in some applications including weaving, knitting, and braiding.In some embodiments, the sheet-like structure may comprise a laminateincluding multiple layers of film with each layer of film defining aplurality of micro-machined or formed holes. The sheet-like structure ofthe tendon repair implant may also comprise a reconstituted collagenmaterial having a porous structure. Additionally, the sheet-likestructure of the tendon repair implant may also comprise a plurality ofelectro-spun nanofiber filaments forming a composite sheet.Additionally, the sheet-like structure may comprise a synthetic spongematerial that defines a plurality of pores. The sheet-like structure mayalso comprise a reticulated foam material. Reticulated foam materialsthat may be suitable in some applications are available from BiomerixCorporation of Fremont, Calif. which identifies these materials usingthe trademark BIOMATERIAL™. The sheet-like structure may be circular,oval, oblong, square, rectangular, or other shape configured to suit thetarget anatomy.

Various attachment elements may be used to fix tendon repair implant 50to distal tendon 28 without deviating from the spirit and scope of thisdetailed description. Examples of attachment elements that may besuitable in some applications include sutures, tissue anchors, boneanchors, and staples. In the embodiment of FIG. 14, sheet-like implant50 is affixed to distal tendon 28 by a plurality of tendon staples 51.Sheet-like implant 50 is affixed to humerus 14 by a plurality of bonestaples 100 as described with respect to the exemplary embodiment ofFIG. 1 and detailed throughout this disclosure.

In some exemplary methods, a plurality of staples may be applied using afixation tool. After the staples are applied, the fixation tool may bewithdrawn from the body of the patient. Distal tendon 28 meets humerus14 at an insertion point 30. With reference to FIG. 14, it will beappreciated that sheet-like implant 50 extends over insertion point 30.Tendon repair implant may be applied to distal tendon 28, for example,using the procedure illustrated in the previous Figures. In variousembodiments, staples may straddle the perimeter edge of the sheet-likeimplant (as shown in FIG. 14), may be applied adjacent to the perimeter,and/or be applied to a central region of the implant. In someembodiments, the staples may be used to attach the implant to softtissue and/or to bone.

Staples or fasteners 100, as exemplified in FIG. 1 and described andillustrated herein can be used to attach tissue and implants to bone. Inat least some embodiments, the staple is generally flexible. With thisflexibility, the fasteners cannot be pounded or driven into bone orother tissue as a conventional hard staple would be driven into paper,wood, tissue or bone. Therefore, for application of the staple of thepresent disclosure to affixing tissue or implants to bone, the staple isgenerally included in a kit that also includes a staple delivery device200 and a pilot hole forming trocar assembly 300, as schematicallyillustrated in FIGS. 15A and 15B, respectively.

In general, the staple delivery device 200 can include a handle assembly201 and a barrel assembly 205. The handle assembly 201 includes atrigger 203 that is operatively coupled to mechanisms in the barrelassembly 205 to deploy a staple of the present disclosure in bone. Thestaple delivery device 200 can be used in conjunction with the pilothole forming trocar assembly 300 of FIG. 15B.

The exemplary pilot hole forming trocar assembly 300, illustratedgenerally in FIG. 15B, includes a trocar 302 and a position retentionsleeve 304. The trocar 302 is releasably coupled to the positionretention sleeve 304 and slides in keyed arrangement within the sleeve304 when uncoupled. The trocar 302 includes a distal portion having aretractable blade 306 and a pair of pilot hole forming spikes 308extending distally from the trocar shaft. The retractable blade 306 isuseful in inserting the assembly through an incision. The retractableblade 306 can be retracted by activating release button 315 which causesa spring (not shown) to pull the retractable blade 306 into the shaft ofthe trocar within the position retention sleeve 304. In this theposition, the pilot hole forming spikes remain extended from the shaft.In some embodiments the retractable blade 306 can be omitted, such aswhen the pilot hole forming trocar assembly is to be inserted into anincision that already has a cannula extending therethrough to provide aninstrument path.

Referring to FIGS. 16A-16C, details of the elements of one exemplaryembodiment of a pilot hole forming trocar assembly 300 are illustrated.The pilot hole forming trocar assembly is used to create pilot holes ina bone for subsequent placement of a staple or fastener, such as staple100 of FIG. 1. Further, the pilot hole forming trocar assembly includesa means for retaining instrument position with respect to the pilotholes when the trocar is removed so that a staple delivery device 200can be inserted and the staple be in alignment with the already formedpilot holes. This prevents the time and difficulty associated withfinding the pilot holes with the staple, which in fact may not bepossible for many practitioners.

As previously stated, a pilot hole forming trocar assembly 300 caninclude a trocar 302 and a position retention sleeve 304. One embodimentof a position retention sleeve 304 is illustrated in FIG. 16A. Theposition retention sleeve 304 includes a shaft 311 having a lumen 310extending therethrough. The lumen 310 is sized to receive the trocar 302when used to form pilot holes. The lumen 310 is also sized to receive astaple delivery device 200 when used to position a staple in pilot holeformed in bone. The lumen is shaped or keyed to cooperate with either ofthese instruments or other instruments so that relative rotationalposition of the trocar 302 or staple delivery device 200 is fixed whenslidably positioned in the position retention sleeve. An opening orwindow 313 may be included near the distal end of the position retentionsleeve to allow viewing of devices inserted therein.

Position retention members 314 extend distally from the shaft 311. Asdetailed in FIG. 16C, the position retention members can be included onan insert 312 that is affixed proximate the distal end of the shaft 311.Alternatively, the position retention members can be integral to theshaft 311. The position retention members are sized and designed toextend into pilot holes as they are formed by the trocar 302 describedbelow. When the trocar 302 is removed, the position retention members314, along with the sleeve 311 remain in position to provide a guide forthe staple delivery device 200 to be inserted into proper position andposition a staple 100 in the pilot holes. As depicted, the positionretention members 314 can include longitudinally extendingsemi-cylindrical projections. In the disclosed embodiment, the pilothole forming spikes 308 of the trocar 302 slide within the partiallumens of the position retention members 314. This design can providesupport for the spikes as they are pounded into bone and can also allowthe position retention members to readily slide into pilot holes formedby the spikes 308.

A more detailed depiction of another exemplary embodiment of a trocar302 is included in FIG. 16B. The trocar includes a shaft 320 having atits proximal end a knob 324 that can be used to pound or push the trocar302 into bone. The trocar can further include a collar 322 which can beused to releasable engage the position retention sleeve 304 when the twoare mated for forming pilot holes. A spring 323 can be included whichcauses or aids the retraction of the trocar when it is released from theposition retention sleeve.

As previously disclosed, the distal end of the trocar 302 includes twopilot hole forming spikes 308 extending from shaft 320. A retractableblade 306 is positioned between the spikes 308. In use, the blade 306 isretracted prior to the spikes 308 being used to form pilot holes inbone.

Now referring to FIGS. 17A-17B, a perspective view of a distal portion207 of a staple delivery assembly 210 is illustrated. The stapledelivery assembly 210 would be slidably disposed within a barrel 205 ofa staple delivery device 200 as previously depicted in FIG. 15A. Astaple 100 of the present disclosure is shown mounted on the distalportion 207 and the barrel is not shown to better view operation of thestaple delivery device 200 in deploying a staple within bone. Aspreviously discussed, staples of the present disclosure can be flexibleand further are particularly useful in affixing an implant to bone. Assuch, the staples cannot be pounded in bone like a conventional staple.Therefore a method and apparatus for forming pilot holes has beendisclosed that can be used with a staple delivery device that places thestaple in the pilot holes so that claws can be extended to interact withthe bone and provide holding strength to the staple.

FIGS. 17A and 17B depict a mechanism included on at least some stapledelivery devices 200 that holds the staple in proper position while theclaws are deployed into the bone. In FIG. 17A staple 100 having claws130 disposed within the trunks 120 in a retracted position isillustrated. Further, pull members 160 are illustrated in engagementwith a notch in claws 130. The pull members 160 are releasably attachedto a deployment rod 240 which is only partially depicted. In a stapledelivery device 200, such as that depicted in FIG. 15A, the deploymentrod would extend proximally into the handle assembly and be mechanicallycoupled to the trigger such that squeezing the trigger causes thedeployment rod 240 to retract proximally pulling on the pull members160. Also depicted in FIG. 17A are staple setting rods 242. These areshown in phantom so as not to obscure the other features of the distalportion of the staple delivery device. The staple setting rods engage aproximal surface 243 of the trunks 120 and extend through the barrel tothe handle. Further, in the embodiment depicted, the deployment rodtravels in grooves 243 formed into the staple setting rods. Thecombination of the pull members 160, deployment rod 240 and staplesetting rods 242 provide longitudinal support and strength for thestaple to be inserted into the pilot holes in bone. The staple settingrods urge the staple into position within the pilot holes and continueto hold it there while the deployment rod 240 is retracted. This isshown in FIG. 17B where it can be seen that claws 130 have been deployedby retraction of the deployment rod 240 while the staple setting rodsremain engaged with the proximal surfaces.

A process of forming pilot holes and delivery of staples of the presentdisclosure to bone is described with respect to FIGS. 18A-18F whichdepict the various steps in affixing an implant 50 to bone with staplesor fasteners of the present disclosure. FIG. 18A schematically depicts ashoulder 22 of a patient 20 having an implant 50 positioned over asupraspinitus tendon 28. The implant is partially affixed to the tendon28 with fasteners 51 and extends laterally to and over the insertionpoint of the tendon to the humeral head 24. As depicted, the implant 50is not yet affixed to the humeral head 24. A distal portion of a pilothole forming trocar assembly 300, in particular the position retentionsleeve 304, is disposed over a desired location near the lateral edge ofthe implant 50 where it overlies the humeral head 24. It is noted theFIG. 18A is a depiction with all overlying tissue removed from theshoulder 22 to clearly show the location of the entire implant 50 on thesupraspinitus tendon 28. This view is typically not possible duringactual arthroscopic procedures in which the fasteners and instruments ofthe present disclosure can be used, however the depiction provides aclear understanding of the placement of an implant and the use offasteners disclosed herein. In actual use the surgeon will typicallyhave a side view from a viewing scope (not shown) of a small spacecreated by inflating the area with fluid and clearing necessaryobstructions from the implant area.

FIG. 18B is a schematic illustration of a cross-sectional side view ofthe partially affixed implant of FIG. 18A showing the small portion ofthe implant 50 that is not yet affixed to the humeral head 24. As can beseen in the illustration, the humeral head 24 is shown in cross-sectionwhich illustrates the composite nature of bone structure. In general,bone includes hard outer portion or cortical layer 375 and a poroussofter inner portion or cancellous bone 376. The pilot hole formingtrocar assembly 300 is positioned with the spikes 308 over a selectedposition on the implant 50. As previously discussed, the trocar 302 ispositioned within the lumen of the position retention sleeve 304 withspikes 308 extending distally. The spikes 308 can be used to manipulateand position the implant as needed. Once in position, the spikes 308 canbe driven into the bone.

Referring to FIG. 18C, the illustration of FIG. 18B is re-illustratedwith the pilot hole forming trocar 300 spikes pounded or otherwisedriven into the humeral head 24, penetrating the cortical layer 375 intothe cancellous portion 376. As illustrated, position retention members314 also penetrate the bone with the spikes 308. In FIG. 18D, it isillustrated that the trocar 302 and its distal spikes 308 are nowremoved leaving formed pilot holes 309 with the position retentionsleeve 304 remaining in position with position retention member 314extending into pilot holes 309. The position retention member 304 lumenprovides a guide to the pilot holes 309 for a staple delivery device200. In FIG. 18E, a staple 100 is shown extending into the pilot holes309 as mounted on the distal end of a staple delivery device 200 thathas been inserted into the lumen of position retention member 304. Inthis position the staple can be delivered and retained in the bone aspreviously described in the various embodiments disclosed herein. FIG.18F depicts a staple 100 as delivered into bone with bridge 304 holdingthe implant in position on the bone and arms of the staple retainingposition in the bone, such as within the cancellous portion 376.

While exemplary embodiments of the present invention have been shown anddescribed, modifications may be made, and it is therefore intended inthe appended claims and subsequently filed claims to cover all suchchanges and modifications which fall within the true spirit and scope ofthe invention.

What is claimed is:
 1. A multi-component staple for attachment to bone,comprising: a monolithic structure including: a first trunk portion; asecond trunk portion; and a bridge having a first end connected to aproximal end of the first trunk portion and a second end connected to aproximal end of the second trunk portion; wherein the first trunkportion and the second trunk portion extend distally from the bridge toform the monolithic structure; an elongated first retention memberassociated with the first trunk portion and movable relative to thefirst trunk portion, the elongated first retention member having a baseand a tip opposite the base; an elongated second retention memberassociated with the second trunk portion and movable relative to thesecond trunk portion, the elongated second retention member having abase and a tip opposite the base; wherein the first and second retentionmembers are movable relative to the first and second trunk portions,respectively, from a first, delivery configuration to a second, deployedconfiguration; wherein the tip of the first retention member moves awayfrom a longitudinal axis of the first trunk portion as the firstretention member moves from the first configuration to the secondconfiguration and the tip of the elongated second retention member movesaway from a longitudinal axis of the second trunk portion as the secondretention member moves from the first configuration to the secondconfiguration.
 2. The staple of claim 1, wherein the base of the firstretention member is positioned in a cavity of the first trunk portion.3. The staple of claim 2, wherein the base of the first retention membermoves along the longitudinal axis of the first trunk portion in thecavity of the first trunk portion as the first retention member movesfrom the first configuration to the second configuration.
 4. The stapleof claim 3, wherein the base of the second retention member ispositioned in a cavity of the second trunk portion.
 5. The staple ofclaim 4, wherein the base of the second retention member moves along thelongitudinal axis of the second trunk portion in the cavity of thesecond trunk portion as the second retention member moves from the firstconfiguration to the second configuration.
 6. The staple of claim 5,wherein the tip of the first retention member extends laterally from aside opening of the first trunk portion in the second configuration. 7.The staple of claim 6, wherein the tip of the second retention memberextends laterally from a side opening of the second trunk portion in thesecond configuration.
 8. The staple of claim 1, wherein the firstretention member rotates relative to the first trunk portion from thefirst configuration to the second configuration and the second retentionmember rotates relative to the second trunk portion from the firstconfiguration to the second configuration.
 9. The staple of claim 1,further comprising: a first deployment member configured and adapted tomove the elongated first retention member from the first configurationto the second configuration; and a second deployment member configuredand adapted to move the elongated second retention member from the firstconfiguration to the second configuration.
 10. The staple of claim 9,wherein a distal end of the first deployment member is detachablycoupled to the first retention member in the first configuration anddetached from the first retention member in the second configuration.11. The staple of claim 10, wherein the distal end of the firstdeployment member includes a mechanically interlocking but releasableconnection with the first retention member.
 12. The staple of claim 11,wherein a distal end of the second deployment member is detachablycoupled to the second retention member in the first configuration anddetached from the second retention member in the second configuration.13. The staple of claim 12, wherein the distal end of the seconddeployment member includes a mechanically interlocking but releasableconnection with the second retention member.
 14. A multi-componentstaple for attachment to bone, comprising: a monolithic structureincluding: a first trunk portion; a second trunk portion; and a bridgehaving a first end connected to a proximal end of the first trunkportion and a second end connected to a proximal end of the second trunkportion to form the monolithic structure; wherein the first trunkportion extends distally from the bridge along a first longitudinal axisand the second trunk portion extends distally from the bridge along asecond longitudinal axis; an elongated first retention member associatedwith the first trunk portion and movable relative to the first trunkportion, the elongated first retention member having a base and a tipopposite the base; an elongated second retention member associated withthe second trunk portion and movable relative to the second trunkportion, the elongated second retention member having a base and a tipopposite the base; wherein the first and second retention members aremovable relative to the first and second trunk portions, respectively,from a first, delivery configuration to a second, deployedconfiguration; wherein the tip of the first retention member rotatesaway from the first longitudinal axis of the first trunk portion as thefirst retention member moves from the first configuration to the secondconfiguration and the tip of the elongated second retention memberrotates away from the second longitudinal axis of the second trunkportion as the second retention member moves from the firstconfiguration to the second configuration.
 15. The staple of claim 14,wherein the first longitudinal axis is parallel to the secondlongitudinal axis.
 16. The staple of claim 14, further comprising: afirst deployment member configured and adapted to move the elongatedfirst retention member from the first configuration to the secondconfiguration; and a second deployment member configured and adapted tomove the elongated second retention member from the first configurationto the second configuration.
 17. The staple of claim 16, wherein: adistal end of the first deployment member is detachably coupled to thefirst retention member in the first configuration and detached from thefirst retention member in the second configuration; and a distal end ofthe second deployment member is detachably coupled to the secondretention member in the first configuration and detached from the secondretention member in the second configuration.
 18. The staple of claim17, wherein: the distal end of the first deployment member includes amechanically interlocking but releasable connection with the firstretention member; and the distal end of the second deployment memberincludes a mechanically interlocking but releasable connection with thesecond retention member.
 19. The staple of claim 18, wherein the firstretention member is a first claw and the second retention member is asecond claw.
 20. The staple of claim 14, wherein: the tip of the firstretention member extends laterally from a side opening of the firsttrunk portion in the second configuration; and the tip of the secondretention member extends laterally from a side opening of the secondtrunk portion in the second configuration.